Study on the Effectiveness of Platelet Concentrate and Shockwave Therapy for Men with Mild to Moderate Erectile Dysfunction

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What is this study about?

This clinical trial is focused on studying the treatment of erectile dysfunction, a condition where a man has difficulty achieving or maintaining an erection. The treatment being tested involves the use of Platelet Concentrate, which is a solution made from a person’s own blood. This solution is injected locally to help improve the condition. The study also includes the use of Focal Shockwave Therapy, a technique that uses sound waves to stimulate blood flow and tissue repair in the affected area.

The purpose of the study is to evaluate how effective and safe this combined treatment is for men with moderate or mild to moderate erectile dysfunction. Participants will receive either the treatment or a placebo. The study will last for several weeks, during which participants will receive injections and undergo shockwave therapy. The effectiveness of the treatment will be assessed by improvements in a questionnaire that measures erectile function.

Throughout the study, participants will be monitored for any side effects related to the treatment. The goal is to determine if this approach can significantly improve erectile function and overall sexual quality of life. The study will also track changes in the ability to achieve vaginal penetration and any improvements in sexual satisfaction over time.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the participant is a man over 18 years of age with erectile dysfunction present for more than 3 months in more than 50% of sexual intercourses.

The participant must have a baseline IIEF-EF questionnaire score between 11 and 21 and be in a stable heterosexual relationship of at least 6 months.

2 informed consent

The participant voluntarily agrees to enter the study by signing an informed consent form, acknowledging understanding of the study’s procedures and requirements.

3 treatment phase

The treatment involves the administration of platelet concentrate through local injection. This is part of the combined therapy with focal shockwave treatment.

The objective is to evaluate the effectiveness of intracavernous autologous platelet-rich plasma therapy for the treatment of moderate or mild to moderate erectile dysfunction.

4 treatment duration

The treatment is conducted over a period of 12 weeks. During this time, participants are required to refrain from using other natural, oral, or intracavernous pharmacological treatments.

5 follow-up assessments

After completing the treatment, follow-up assessments are conducted at weeks 13, 21, and 33 to measure changes in the IIEF-EF score, EHS score, and other related questionnaires.

The primary endpoint is the change in IIEF-EF score between baseline and week 21.

6 final evaluation

The final evaluation includes assessing the proportion of participants achieving the minimum clinically meaningful difference in IIEF-EF score, changes in sexual quality of life, and any adverse events related to the treatment.

Who Can Join the Study?

Men over 18 years of age.
Have had erectile dysfunction for more than 3 months, affecting more than 50% of sexual activities.
Have a starting score between 11 and 21 on the IIEF-EF questionnaire, which is a survey used to measure erectile function.
Be in a stable heterosexual relationship for at least 6 months.
Agree to have at least 3 vaginal sexual activities per month after finishing the treatment.
Agree not to use other natural, oral, or injected medications for erectile dysfunction during the treatment and for up to 6 months after it ends.
Willingly agree to participate in the study by signing a document called an informed consent.

Who Cannot Join the Study?

Patients who are not male cannot participate.
Patients who are under 18 years old cannot participate.
Patients who have severe erectile dysfunction cannot participate. This means the condition is more serious than moderate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that might need special protection, like people with certain disabilities or those who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bpyazj Mphaqms Gwrer Ssyfg Sekp	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	12.04.2024

Trial locations

Investigated drugs:

Platelet Concentrate

Platelet Rich Plasma (PRP) is a therapy that uses a concentration of a patient’s own platelets to promote healing. In this trial, PRP is injected into the penis to help improve erectile function. The goal is to see if this treatment can help men with moderate or mild to moderate erectile dysfunction by improving their ability to achieve and maintain an erection.

Focal Shockwave Therapy is a non-invasive treatment that uses sound waves to improve blood flow to the penis. This therapy aims to enhance erectile function by stimulating the growth of new blood vessels and improving circulation. In this trial, it is used in combination with PRP to assess its effectiveness in treating erectile dysfunction.

Investigated diseases:

Erectile dysfunction

Erectile Dysfunction – Erectile dysfunction is a condition where a man has difficulty achieving or maintaining an erection sufficient for sexual intercourse. It can result from physical issues such as heart disease, diabetes, or hormonal imbalances, as well as psychological factors like stress or anxiety. The condition may develop gradually, with occasional difficulties progressing to more frequent or persistent problems. It can affect self-esteem and relationships, leading to emotional distress. The severity of erectile dysfunction can vary, with some men experiencing complete inability to achieve an erection, while others may have inconsistent or brief erections.

Trial ID:

2024-517248-73-00

NCT ID:

NCT06433596

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effectiveness of Platelet Concentrate and Shockwave Therapy for Men with Mild to Moderate Erectile Dysfunction

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?